Job ID :
US - California - San Jose
- Works with R&D in conjunction with supplier on New Product Introduction (NPI) projects.
- Leads supplier development activities by conducting reviews and visiting supplier sites focusing on developing and implementing improvements/modes of control within the supplier processes to minimize non-conformances.
- Establishes and reports on quality benchmarks and metrics for measuring efficiencies and effectiveness of all supplier performances that affect Thermo Fisher Scientific products and services.
- Develops initiatives and reviews metrics to identify cost of poor supplier quality. Using various data collection methodologies, will measure, analyze and improve Supplier performance and reduce supplier non-conformances.
- Ensure Quality Assurance for existing suppliers including source inspection, review of incoming raw materials (as required), and change control process management.
- Drive continuous improvement process (CIP) activities such as PPI, Kaizen, Lean
- Review supplier manufacturing process and collaborate with them on process improvement opportunities
- Perform and maintain product/process risk analysis and ensure mitigations are implemented and effective (Supplier Process FMEA)
- Execute Lead Auditor function for assigned suppliers based on ISO 9001, 13485 and 21CFR820 clauses
- Ownership/leadership mindset
- B.S. degree in engineering or related technical field, or equivalent experience
- 0-5 year’s experience with manufacturing, assembly and test
- Experience with manufacturing support of electromechanical devices
- Experience in an ISO/FDA regulated environment, including manufacturing support, and process improvement is required.
- Experience with New Product Development, including verification, validation and FMEA
- Proficient in use of statistical analysis and methods such as Lean, 5 Why’s, Pareto Analysis, SPC, FMEA, Six Sigma, etc.
- Must have excellent written and verbal communication skills with ability to clearly articulate requirements
- Experience using MS Office suite.
- Ability to travel up to 25% domestically and internationally
- BS in Electrical Engineering
- Supply Chain Knowledge
- Experience using statistical tools such as Minitab, QC Calc, etc.
- Knowledge of RoHS requirements.
- SAP experience a plus
- ASQ Certified Quality Engineer
- Qualified lead auditor certification or equivalent training in ISO or GMP standards.